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Abstract Background Patient engagement has become increasingly important in drug development, yet structured guidance to engage children (2–11 years old), adolescents (12–17 years old), and young adults (18–24 years old) is lacking. This study aims to create a matrix tool to foster paediatric patient engagement in drug development by hosting a multistakeholder workshop. Methods A matrix tool was co-developed by the study team and the expert group to provide a framework for paediatric patient engagement across drug development stages. The matrix tool’s concept was evaluated using a Delphi-based approach. A pre-workshop questionnaire was sent to 55 experts, followed by an online multistakeholder workshop with 38 participants. A post-workshop questionnaire was redistributed to the initial participants refine the matrix tool further. Results The pre-workshop questionnaire (34 respondents) confirmed the need for a co-developed matrix tool, with all statements reaching consensus (cut-off 70% consensus). The workshop (38 participants) revealed strong agreement (92%) on the necessity of such a matrix tool. Participants emphasized the importance of including both chronic and acute diseases, considering patient trial experience, involving families and patient organizations, and aligning age group categories with regulations. The post-workshop questionnaire (18 respondents) showed 89% agreement on involving children, adolescents, and young adults in the matrix tool’s co-development. However, opinions varied on the appropriate minimum age for engagement, ranging from 2 to 17 years. Conclusions This study presents the initial steps towards developing a matrix tool to enhance paediatric patient engagement in drug development. The multistakeholder approach provided valuable insights into the matrix tool’s structure and content. While further validation and refinement are needed, particularly regarding practical implementation and global applicability, this initiative lays the groundwork for more effective and inclusive paediatric drug development processes. Future research should focus on validating the matrix tool across different age groups and disease contexts, incorporating real life experiences, and addressing cultural and linguistic considerations. |
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